System and method for a tissue resection margin measurement device

ABSTRACT

Embodiments of the invention provide a system and method for resecting a tissue mass. The system for resecting a tissue mass includes a first sensor for measuring a signal corresponding to the position and orientation of the tissue mass. The first sensor is dimensioned to fit inside of or next to the tissue mass. The system also includes a second sensor attached to a surgical instrument configured to measure the position and orientation of the surgical instrument. A controller is in communication with the first sensor and the second sensor, and the controller executes a stored program to calculate a distance between the first sensor and the second sensor. Accordingly, visual, auditory, haptic or other feedback is provided to the clinician to guide the surgical instrument to the surgical margin.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application is a continuation of U.S. Pat. Application No.17/590,216, filed Feb. 1, 2022, which is a continuation of U.S. Pat.Application No. 17/420,528, filed Jul. 2, 2021, and issued as U.S. Pat.No. 11,234,732 on Feb. 1, 2022, which is a national phase ofPCT/US2020/056114, filed on Oct. 16, 2020; and claims benefit of:

-   (1) pending prior U.S. Provisional Pat. Application Serial No.    62/923,137, filed Oct. 18, 2019 by Raphael Bueno et al. for SYSTEM    AND METHOD FOR A TISSUE RESECTION MARGIN MEASUREMENT DEVICE    (Attorney’s Docket No. 129319.00702.BWH22238); and-   (2) pending prior U.S. Provisional Pat. Application Serial No.    63/054,921, filed Jul. 22, 2020 by Raphael Bueno et al. for SYSTEM    AND METHOD FOR A TISSUE RESECTION MARGIN MEASUREMENT DEVICE    (Attorney’s Docket No. 129319.00734.BWH2020-564).

The above-identified patent applications are hereby incorporated hereinby reference.

FIELD OF THE INVENTION

This invention relates to surgery in general, and more particularly tocomputer-assisted surgery.

BACKGROUND OF THE INVENTION

Minimally invasive surgical resection of lesions involves the preciseexcision of the lesion while sparing surrounding healthy and criticaltissue. Some examples include, but are not limited to, breast conservingsurgery and Video-Assisted Thoracic Surgery (VATS). Surgical resectionof the lesion requires the removal of a margin of tissue around thelesion to ensure complete removal of the lesion cells and improvedlong-term survival. The default margin is dependent on the type oflesion and micro-invasion of the lesion into the surrounding tissue.While this is particularly true in cancer, where the size of theoriginal lesion and the margin of normal tissue resected with the lesionis associated with survival, this is also true for non-cancerouslesions. Significant deformation of the tissue due to highviscoelasticity, physiological motion (such as collapsing of the lung,breathing or beating motion), or tissue manipulation can lead todifficulty in localizing the lesion and precise removal of the lesion.As a result, this can lead to insufficient resection, lesion recurrencelocally, or by metastasis (in cancer), and poorer long-term benefitscompared with cases where a sufficient margin is obtained. Two surgicalapplications are listed below as an example. However, the disclosedsystem and method may be applied for resection or biopsy of otherlesions through a minimally invasive or image-guided approach oropen-surgery, or a combination of approaches.

Lung Lesion Surgery

Current clinical practice to remove lung tissue segments involvesopening the chest by cutting the sternum or by spreading the ribs. Manytimes ribs are broken and often segments are surgically removed duringthese procedures. The orthopedic trauma alone presents considerable painand it can complicate the recovery process with patients. Thoracic painof this magnitude also complicates the task of recovering a patient fromgeneral anesthesia since the body acclimates to forced ventilation andthe pain can interrupt natural chest rhythm. Patients benefitdramatically from procedures that are performed through small incisionsor ports in the chest without causing this orthopedic trauma.

Even though minimally invasive or VATS techniques are well known toprovide benefit to the patient by minimizing trauma and speedingrecovery times compared to open chest procedures, a substantial numberof open chest procedures are currently still performed. This is due, atleast in part, to the fact that there are only a limited number ofinstruments designed specifically to facilitate thoracic procedures inthis way.

Surgery for lung cancer, however, is moving to a minimally invasiveapproach using VATS and smaller anatomic or non-anatomic lung resection(e.g., a wedge resection or segmentectomy) particularly for smalllesions. In the conventional method of performing VATS, however, thelung is collapsed during surgery, leading to difficulty in preciselylocating the lesion and determining the resection margins. Additionally,palpation of lung tissue is not always possible (particularly in thecase of smaller or early stage cancers) due to the minimally invasiveapproach to surgery. Imprecise surgical resection could lead toincomplete resection and subsequent lesion recurrence.

Breast Lesion Surgery

Breast conserving surgery (BCS) involves the removal of the lesion whilesparing the healthy breast parenchyma around the lesion. Studies haveshown that BCS combined with chemotherapy has similar long-term benefitsas mastectomy with the additional cosmetic advantage. However,identifying and resecting the entire lesion is a challenging task due tothe highly deformable nature of the breast. Achieving the negativesurgical margin with minimal damage to the healthy parenchyma isnon-trivial due to the soft-tissue nature of the breast. In fact,studies show that up to 25% of breast resections leave positive marginsand require re-treatment.

Therefore, a tissue resection margin measuring device is needed thatovercomes the above limitations by providing an improved approach forprecisely locating a lesion and determining the resection margins.

SUMMARY OF THE INVENTION

The present invention relates to a system and method for resecting atissue mass while compensating for tissue deformation due to its elasticnature and physiologically induced motion. In a non-limiting example,the invention enables minimally invasive surgical procedures byproviding a device and method to perform tissue resection thatdiscriminates against traumatizing critical tissue and preciselydetermines the resection margin. Additionally, auditory, visual andhaptic cues may be provided to the surgeon to identify and moreprecisely measure the lesion margins and critical structures surroundingthe lesions to ensure complete and safe resection of the lesion.

Some embodiments of the invention provide a system for resecting atissue mass. The system includes a surgical instrument and a firstsensor for measuring a first signal. The first sensor is dimensioned tofit inside of or next to (e.g., in close proximity to) the targetlesion/tissue mass, usually at a location between the tissue mass andthe ultimate cut area-margin. The system also includes a second sensorfor measuring a second signal, and the second sensor is coupled to thesurgical instrument. A controller is in communication with the firstsensor and the second sensor, and the controller executes a storedprogram to calculate a distance between the first sensor and the secondsensor based on the first signal and the second signal.

In some embodiments the system may further include a sleeve dimensionedto engage at least one of a housing of the surgical device and thesecond sensor. The second sensor may be coupled to the housing of thesurgical instrument by an adhesive, for example. The surgical device maybe, for example, a stapler, a Bovi pencil or a cutting device configuredto cut along a resection margin surrounding the target tissue mass,which may be a lesion (e.g., a tumor, a nodule, etc.). The resectionmargin may be included within the distance calculated between the firstsensor and the second sensor. Other factors may be included incalculating the margins, such as the distance between the mass and thefirst sensor, and the configuration of the mass.

In one embodiment, the first signal received by the first sensor canindicate a position and an orientation of the tissue mass relative tothe surgical instrument in real time. Similarly, the second signalreceived by the second sensor can indicate a position and an orientationof the surgical instrument relative to the tissue mass. In oneembodiment, the second sensor indicates a position and an orientation ofthe surgical instrument in the same frame of reference as the firstsensor. The first sensor may be a fiducial marker (sometimes referred toas a fiducial sensor or a fiducial tracker) embedded within an anchormade from superelastic material, and the second sensor may be aninstrument sensor (sometimes referred to as an instrument tracker). Inone embodiment, the first sensor may be configured to measure a positionand an orientation of the tissue mass, and the second sensor may beconfigured to measure a position and an orientation of the surgicalinstrument.

In one embodiment, the system may further include a third sensor formeasuring a third signal. The third sensor may be dimensioned to fitnext to the tissue mass at a position opposite the first sensor, suchthat the third signal received by the third sensor indicates a positionand an orientation of the tissue mass relative to the first sensor.

In one embodiment, the first sensor may be embedded within a hookstructure made of a superelastic material, e.g., Nitinol. The hookstructure may be in the form of a T-bar or J-bar and dimensioned to fitinside a delivery needle and/or a sheath. The delivery needle and/or thesheath may be configured to guide the first sensor, and the hookstructure may be configured to anchor the first sensor within the tissuemass. In one embodiment, the first sensor that is embedded within thehook structure may be inserted into the tissue mass under real-timeimage guidance.

In one embodiment, the first sensor is embedded within a hook structurethat includes a plurality of prongs, and the first sensor may bedimensioned to fit inside a delivery needle and/or a sheath. Thedelivery needle and/or the sheath may be configured to guide the firstsensor, and the plurality of prongs may be configured to anchor thefirst sensor within the tissue mass. The hook structure may furthercomprise a plurality of extensions extending from a tube portion of thehook structure, such that the plurality of extensions may be dimensionedto receive the first sensor.

The system may further include a display in communication with thecontroller. The display may be coupled to the surgical instrument andconfigured to display the distance between the first sensor and thesecond sensor as calculated by a stored program executed by thecontroller, which may also be configured to include additionalcalculations. Distances from the base, mid and tip of the surgicalinstrument (e.g., a cutting instrument such as a stapler) can also bedisplayed. The display may be, but is not limited to, an OLED display oran LCD display. In one embodiment, the system may include an audiblesource for emitting an audible signal. The audible source may be incommunication with the controller, which is configured to execute astored program to alter the audible signal based on the distance betweenthe first sensor and the second sensor. In one embodiment, the storedprogram is a navigation system.

The system may further include a piezoelectric actuator coupled to ahandle of the surgical instrument. The piezoelectric actuator may beconfigured to emit a haptic signal. The piezoelectric actuator may be incommunication with the controller, which is configured to execute astored program to alter the haptic signal based on the distance betweenthe first sensor and the second sensor.

The system may further include a monitor for emitting a visual signal insome embodiments. The monitor may be in communication with thecontroller, which is configured to execute a stored program to alter thevisual signal based on the distance between the first sensor and thesecond sensor. Additionally or alternatively, the system may include amonitor for displaying a video overlay. The monitor may be incommunication with the controller, which is configured to execute astored program to fuse a laparoscopy, thoracoscopy or endoscopy image(i.e., a “scope image”) with a virtual model image (i.e., an imagecomputer-generated from a virtual model of the anatomy), so as to createthe video overlay of the scope image with the virtual model image. Thevideo overlay may be configured to identify a position of the tissuemass and the first sensor.

In one embodiment, the invention provides a method for resection of atissue mass inside a patient. The method includes inserting a firstsensor inside of or next to the target tissue mass (e.g., in closeproximity to the tissue mass) and capturing at least one image of thefirst sensor embedded within or next to (e.g., in close proximity to)the tissue mass. A resection margin is calculated around the tissue massusing the at least one image. A surgical instrument is inserted into thepatient, and the surgical instrument is coupled to a second sensor. Thesecond sensor is tracked relative to the resection margin, and thesurgical instrument is used to cut on the resection margin. The surgeonwill determine, based on the diagnosis and size of the mass, what mightbe the best margin to accomplish. This information may also be used todetermine the exact operation required.

In some embodiments the method may further include dimensioning a sleeveto engage at least one of a housing of the surgical device and thesecond sensor. Or the second sensor may be coupled to the housing of thesurgical instrument by an adhesive, for example. In another embodiment,the sensor may be embedded within the device/instrument, or the sensormay be built into the device/instrument. The surgical device may be, forexample, a stapler, a Bovi pencil or a cutting device configured to cutalong a resection margin surrounding the tissue mass, which may be alesion (e.g., a tumor, a nodule, etc.). The resection margin may beincluded within the distance calculated between the first sensor and thesecond sensor.

In some embodiments, the first signal received by the first sensor canindicate a position and an orientation of the first sensor (and hencethe tissue mass) relative to the surgical instrument in real time.Similarly, the second signal received by the second sensor can indicatea position and an orientation of the surgical instrument relative to thetissue mass. In one embodiment, the second sensor indicates a positionand an orientation of the surgical instrument in the same frame ofreference as the first sensor. The first sensor may be a fiducial markerconstructed from a superelastic material, and the second sensor may bean instrument sensor. In one embodiment, the first sensor may beconfigured to measure a position and an orientation of the tissue mass,and the second sensor may be configured to measure a position and anorientation of the surgical instrument.

In one embodiment, the method may further include providing a thirdsensor for measuring a third signal. The third sensor may be dimensionedto fit next to the tissue mass at a position opposite the first sensor,such that the third signal received by the third sensor indicates aposition and an orientation of the tissue mass relative to the firstsensor.

In some embodiments, the first sensor may be embedded within a hookstructure. The hook structure may be in the form of a T-bar or J-bar anddimensioned to fit inside a delivery needle and/or a sheath. Thedelivery needle and/or the sheath may be configured to guide the firstsensor, and the hook structure may be configured to anchor the firstsensor within the tissue mass. In one embodiment, the first sensor thatis embedded within the hook structure may be inserted into the tissuemass under real-time image guidance or under direct visual guidance.

In one embodiment, the first sensor is embedded within a hook structurethat includes a plurality of prongs, and the first sensor may bedimensioned to fit inside a delivery needle and/or a sheath. Thedelivery needle and/or the sheath may be configured to guide the firstsensor, and the plurality of prongs may be configured to anchor thefirst sensor within the tissue mass. The hook structure may furthercomprise a plurality of extensions extending from a tube portion of thehook structure, such that the plurality of extensions may be dimensionedto receive the first sensor.

The method may further include providing a display in communication witha controller. The display may be coupled to the surgical instrument andconfigured to display the distance calculated by the stored programexecuted by the controller. The display may be, but is not limited to,an OLED display or an LCD display. The display may also includeinformation as to the distances between various sensors, as well as tothe quality of the measurements. In some embodiments, the method mayinclude emitting an audible signal from an audible source. The audiblesource may be in communication with the controller, which is configuredto execute a stored program to alter the audible signal based on thedistance between the first sensor and the second sensor. In oneembodiment, the stored program is a navigation method.

The method may further include emitting a haptic signal from apiezoelectric actuator coupled to a handle of the surgical instrument.The piezoelectric actuator may be in communication with the controller,which is configured to execute a stored program to alter the hapticsignal based on the distance between the first sensor and the secondsensor.

In some embodiments, the method may further include emitting a visualsignal on a monitor. The monitor may be in communication with thecontroller, which is configured to execute a stored program to alter thevisual signal based on the distance between the first sensor and thesecond sensor. Additionally or alternatively, the method may includedisplaying a video overlay on the monitor. The monitor may be incommunication with the controller, which is configured to execute astored program to fuse a laparoscopy/thoracoscopy/endoscopy scopeimage(s) to a virtual model image so as to create the video overlay. Thevideo overlay may be configured to identify a position of the tissuemass and the first sensor.

In one form of the invention, the system may be used to identify thelocation of a particular airway. In this form of the invention, thesystem comprises means for bronchoscopic positioning of a sensor into anairway of the lung. This bronchoscopic positioning of the sensor in anairway of the lung (e.g., by positioning the sensor on a bronchoscope oron a catheter within the brochoscope and advancing the bronchoscope intothe airway of interest) can be used to define the lobar, segmental orsubsegmental bronchus for surgery such as segmentectomy, lobectomy orwedge resection during the actual operation. This function can beindependent of the lesion margin measurement, and the position of thesensor identifying the bronchus can be correlated with the position ofanother device (e.g., a surgical instrument) carrying another sensor sothat the surgeon can define the correct bronchus for surgery from thechest side of the operation. Thus, in this form of the invention, onesensor is positioned on a bronchoscope or on a catheter placed withinthe bronchoscope which is inserted into a specific airway so as todefine the location of that specific airway, and another sensor ispositioned on a surgical instrument which is advanced for surgery fromthe chest side of the operation, with the system continuously trackingthe position of the sensor on the surgical instrument vis-à-vis theposition of the sensor on the bronchoscope, so that the surgeon cancontinuously track the location of the surgical instrument relative tothe airway of interest (identified by the sensor on the bronchoscope),e.g., to target the airway identified by the sensor on the bronchoscope,to avoid the airway identified by the sensor on the bronchoscope, etc.

In one form of the invention, the system comprises means for mapping andtracking airways surrounding a lesion.

In one form of the invention, the system comprises means forbronchoscopic deployment of the fiducial sensor or another sensor intotissue (e.g., bronchoscopic deployment of the fiducial sensor into themass or adjacent to the mass).

In one form of the invention, the system comprises means for measuringthe articulation of a surgical stapler.

In one form of the invention, the system comprises means for marking theboundary of a resection margin of a lesion and positioning a surgicalstapler adjacent to the boundary of a resection margin of a lesion.

In one form of the invention, there is provided a method for determiningthe position of an instrument relative to a selected lumen in ananatomical structure, the method comprising:

-   positioning a tracked catheter in the selected lumen of the    anatomical structure, wherein the tracked catheter is tracked    relative to a given frame of reference; and-   determining the position of a tracked instrument relative to the    tracked catheter, wherein the tracked instrument is tracked relative    to the given frame of reference, whereby to determine the position    of the tracked instrument relative to the selected lumen of the    anatomical structure.

In another form of the invention, there is provided a system fordetermining the position of an instrument relative to a selected lumenin an anatomical structure, the system comprising:

-   a catheter sized to be disposable in the selected lumen of the    anatomical structure;-   a catheter tracker for providing a catheter signal representative of    the position of the catheter tracker relative to a given frame of    reference, the catheter tracker being carried by the catheter;-   an instrument;-   an instrument tracker for providing an instrument signal    representative of the position of the instrument tracker relative to    the given frame of reference, the instrument tracker being carried    by the instrument; and-   a controller for determining the position of the tracked instrument    relative to the tracked catheter, whereby, when the tracked catheter    is disposed in the selected lumen of the anatomical structure, the    controller determines the position of the tracked instrument    relative to the selected lumen in the anatomical structure.

In another form of the invention, there is provided a method for mappingand tracking a plurality of lumens in an anatomical structure, whereinthe anatomical structure is deformable, the method comprising:

-   providing a virtual model of the anatomical structure while the    anatomical structure is in a first configuration;-   while the anatomical structure is in the first configuration,    positioning a tracked catheter in one of the lumens in the    anatomical structure which is to be mapped and tracked, and    determining the position of the tracked catheter in that lumen so as    to map the position of that lumen;-   repeating the foregoing step for each of the lumens in the    anatomical structure which is to be mapped and tracked so that those    lumens are mapped;-   supplementing the virtual model with the mapped lumens, whereby to    provide a supplemented virtual model of the anatomical structure and    the mapped lumens while the anatomical structure is in its first    configuration;-   maintaining the tracked catheter in one of the mapped lumens of the    anatomical structure as the anatomical structure is deformed from    its first configuration to a second configuration;-   determining the position of the tracked catheter in the anatomical    structure while the anatomical structure is in the second    configuration; and-   modifying the supplemented virtual model so as to represent the    anatomical structure and the mapped lumens while the anatomical    structure is in its second configuration, whereby to provide a    modified supplemented virtual model, wherein modification is    effected by:    -   determining the spatial transformation of the tracked catheter        as the anatomical structure deforms from its first configuration        to its second configuration; and    -   applying the spatial transformation of the tracked catheter to        the mapped lumens of the supplemented virtual model so as to        provide the modified supplemented virtual model of the        anatomical structure and the mapped lumens while the anatomical        structure is in its second configuration.

In another form of the invention, there is provided a method for mappingand tracking a selected lumen in an anatomical structure, wherein theanatomical structure is deformable, the method comprising:

-   positioning a tracked catheter in the selected lumen of the    anatomical structure while the anatomical structure is in a first    configuration;-   determining the position of the tracked catheter while the    anatomical structure is in the first configuration;-   scanning the anatomical structure and the tracked catheter    positioned in the selected lumen of the anatomical structure while    the anatomical structure is in the first configuration;-   creating a virtual model of the scanned anatomical structure and the    tracked catheter positioned in the selected lumen of the anatomical    structure while the anatomical structure is in its first    configuration;-   maintaining the tracked catheter in position within the selected    lumen of the anatomical structure while the anatomical structure    deforms to a second configuration;-   determining the position and orientation of the tracked catheter    while the anatomical structures is in its second configuration,    whereby to determine the position of the selected lumen of the    anatomical structure while the anatomical structure is in the second    configuration; and-   adjusting the virtual model so as to represent the anatomical    structure and the selected lumen while the anatomical structure is    in its second configuration, whereby to provide an adjusted virtual    model, wherein modification is effected by:    -   determining the spatial transformation of the tracked catheter        as the anatomical structure deforms from its first configuration        to its second configuration; and    -   applying the spatial transformation of the tracked catheter to        the selected lumen of the virtual model so as to provide the        adjusted virtual model of the anatomical structure and the        selected lumen while the anatomical structure is in its second        configuration.

In another form of the invention, there is provided a system for mappingand tracking a plurality of lumens in an anatomical structure, whereinthe anatomical structure is deformable, the system comprising:

-   a catheter sized to be disposed in the plurality of lumens of the    anatomical structure which are to be mapped and tracked, and    configured to remain in a selected lumen of the anatomical structure    during deformation of the anatomical structure;-   a catheter tracker for providing a catheter signal representative of    the position of the catheter tracker, the catheter tracker being    carried by the catheter;-   a virtual model of the anatomical structure representing the    anatomical structure while it is in a first configuration; and-   a controller for:    -   (i) determining the position of the tracked catheter as the        tracked catheter is disposed within each of the plurality of        lumens so as to map the plurality of lumens while the anatomical        structure is in its first configuration; and    -   (ii) supplementing the virtual model with the mapped lumens,        whereby to provide a supplemented virtual model of the        anatomical structure and the mapped lumens representing the        anatomical structure while it is in its first configuration.

In another form of the invention, there is provided a system for mappingand tracking a selected lumen in an anatomical structure, wherein theanatomical structure is deformable, the system comprising:

-   a catheter sized to be disposed in the selected lumen of the    anatomical structure and configured to remain in the selected lumen    of the anatomical structure during deformation of the anatomical    structure;-   a catheter tracker for providing a catheter signal representative of    the position of the catheter tracker, the catheter tracker being    carried by the catheter;-   a virtual model of the anatomical structure and the tracked catheter    positioned in the selected lumen of the anatomical structure,    wherein the virtual model is created while the anatomical structure    is in a first configuration; and-   a controller for:    -   (i) determining the position of the tracked catheter after the        anatomical structure has assumed a second configuration; and    -   (ii) adjusting the virtual model of the anatomical structure and        the tracked catheter so that the virtual model conforms to the        position of the tracked catheter when the anatomical structure        is in its second configuration.

In another form of the invention, there is provided a method fortracking a tissue mass disposed in or on an anatomical structure,wherein the anatomical structure comprises at least one lumen, themethod comprising:

-   advancing a scope along the at least one lumen until the distal end    of the scope is disposed in the vicinity of the selected tissue    mass;-   advancing a fiducial sensor through the scope, into the anatomical    structure, and securing the fiducial sensor to the anatomical    structure in the vicinity of the tissue mass; and-   detecting the position of the fiducial sensor within the anatomical    structure.

In another form of the invention, there is provided a method fortracking a tissue mass disposed in or on an anatomical structure,wherein the anatomical structure comprises at least one lumen, themethod comprising:

-   providing a sensor assembly comprising a fiducial sensor and an    electrical lead extending distally from the fiducial sensor, and    providing a deployment assembly comprising a needle cannula and a    pusher, wherein the sensor assembly is slidably disposed in the    needle cannula distal to the pusher;-   advancing a scope along the at least one lumen until the distal end    of the scope is disposed in the vicinity of the selected tissue    mass;-   advancing the needle cannula through the scope, into the anatomical    structure, and through an outer surface of the anatomical structure;-   retracting the needle cannula so as to expose a portion of the    electrical lead extending through the outer surface of the    anatomical structure;-   supplying electrical power to the fiducial sensor via the electrical    lead extending through the outer surface of the anatomical    structure;-   securing the fiducial sensor to the anatomical structure in the    vicinity of the tissue mass by advancing the pusher relative to the    needle cannula or by retracting the needle cannula relative to the    pusher; and-   detecting the position of the fiducial sensor within the anatomical    structure.

In another form of the invention, there is provided a system fordetermining the position of an instrument relative to a tissue masscarried by an anatomical structure, the system comprising:

-   a wireless fiducial tracker for providing a fiducial signal    representative of the position of the wireless fiducial tracker, the    wireless fiducial tracker adapted to be secured in the anatomical    structure in the vicinity of the tissue mass;-   an instrument;-   an instrument tracker for providing an instrument signal    representative of the position of the instrument tracker, the    instrument tracker being carried by the instrument; and-   a controller for determining the position of the tracked instrument    relative to the wireless fiducial tracker.

In another form of the invention, there is provided a system fordetermining the position of an instrument relative to a tissue masscarried by an anatomical structure, the system comprising:

-   a fiducial tracker for providing a fiducial signal representative of    the position and orientation of the fiducial tracker, the fiducial    tracker adapted to be secured in the anatomical structure in the    vicinity of the tissue mass;-   an electrical lead for providing electrical power to the fiducial    tracker, the electrical lead being releasably connected to the    fiducial tracker;-   an instrument;-   an instrument tracker for providing an instrument signal    representative of the position of the instrument tracker, the    instrument tracker being carried by the instrument; and-   a controller for determining the position of the tracked instrument    relative to the fiducial tracker.

In another form of the invention, there is provided a system fordetermining the position and orientation of an instrument relative to atissue mass disposed in or on an anatomical structure, the systemcomprising:

-   a sensor assembly comprising:    -   a fiducial tracker for providing a fiducial signal        representative of the position of the fiducial tracker, the        fiducial tracker adapted to be secured in the anatomical        structure in the vicinity of the tissue mass; and    -   an electrical lead for providing electrical power to the        fiducial tracker, the electrical lead extending distally from        the fiducial tracker;-   an instrument;-   an instrument tracker for providing an instrument signal    representative of the position and orientation of the instrument    tracker, the instrument tracker being carried by the instrument; and-   a controller for determining the position and orientation of the    tracked instrument relative to the fiducial tracker.

In another form of the invention, there is provided a system fordetermining the position and orientation of an instrument relative to atissue mass disposed in or on an anatomical structure, the systemcomprising:

-   a sensor assembly comprising:    -   a fiducial tracker for providing a fiducial signal        representative of the position of the fiducial tracker, the        fiducial tracker adapted to be secured in the anatomical        structure in the vicinity of the tissue mass; and    -   an electrical lead for providing electrical power to the        fiducial tracker, the electrical lead extending distally from        the fiducial tracker;-   a deployment assembly comprising a needle cannula and a pusher,    wherein the sensor assembly is slidably disposed within the needle    cannula distal to the pusher;-   an instrument;-   an instrument tracker for providing an instrument signal    representative of the position and orientation of the instrument    tracker, the instrument tracker being carried by the instrument; and-   a controller for determining the position and orientation of the    tracked instrument relative to the fiducial tracker.

In another form of the invention, there is provided a method fordetermining the position of an end effector of an instrument relative toa tissue mass carried by an anatomical structure, wherein the instrumentcomprises a shaft and the end effector, and wherein the disposition ofthe end effector relative to the shaft is adjustable, the methodcomprising:

-   tracking the position of the tissue mass;-   tracking the shaft of the instrument;-   determining the disposition of the end effector relative to the    shaft; and determining the disposition of the end effector relative    to the tissue mass.

In another form of the invention, there is provided a system fordetermining the position of an end effector of instrument relative to atissue mass carried by an anatomical structure, the system comprising:

-   a wireless fiducial tracker for providing a fiducial signal    representative of the position of the wireless fiducial tracker, the    wireless fiducial tracker adapted to be secured in the anatomical    structure in the vicinity of the tissue mass;-   an instrument comprising a shaft and an end effector, wherein the    disposition of the end effector relative to the shaft is adjustable;-   an instrument tracker for providing an instrument signal    representative of the position of the instrument tracker, the    instrument tracker being carried by the shaft of the instrument;-   a sensor for detecting the disposition of the end effector relative    to the shaft; and-   a controller for determining the position of the tracked instrument    relative to the wireless fiducial tracker.

In another form of the invention, there is provided a method fordirecting the position of an instrument relative to a tissue masscarried by an anatomical structure, the method comprising:

-   determining the tangent lines of the tissue mass;-   tracking the position of the tissue mass;-   tracking the position of the instrument;-   determining the disposition of the instrument relative to the    tangent lines; and-   directing movement of the instrument so that a portion of the    instrument is aligned with the tangent lines.

In another form of the invention, there is provided a system fordirecting the position of an instrument relative to a tissue masscarried by an anatomical structure, the system comprising:

-   a fiducial tracker for providing a fiducial signal representative of    the position of the fiducial tracker, the fiducial tracker adapted    to be secured in the anatomical structure in the vicinity of the    tissue mass;-   an instrument;-   an instrument tracker for providing an instrument signal    representative of the position of the instrument tracker, the    instrument tracker being carried by the instrument; and-   a controller for determining the tangent lines of the tissue mass    and for directing the position of the tracked instrument relative to    the tangent lines.

These and other features, aspects, and advantages of the presentinvention will become better understood upon consideration of thefollowing detailed description, drawings, and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary fiducial sensor beingdeployed through a delivery needle according to one embodiment of thepresent invention.

FIG. 2 is a perspective view of the exemplary fiducial sensor of FIG. 1being deployed through the delivery needle next to a tissue massaccording to one embodiment of the present invention (note that thefiducial sensor may be placed adjacent to the tissue mass so that thefiducial sensor is in contact with the tissue mass or so that thefiducial sensor is slightly spaced from the tissue mass).

FIG. 3 is a perspective view of an additional fiducial sensor and theexemplary fiducial sensor of FIG. 1 being deployed through the deliveryneedle next to the tissue mass according to one embodiment of thepresent invention.

FIG. 4 is a perspective view of an exemplary fiducial sensor embeddedwithin a hook structure according to another embodiment of the presentinvention.

FIG. 5 is a perspective view of the fiducial sensor embedded in thetissue mass of FIG. 2 , with a resection margin surrounding the tissuemass.

FIG. 6 is a perspective view of the fiducial sensor embedded next to thetissue mass of FIG. 2 , with the resection margin surrounding the tissuemass (note that the fiducial sensor may be placed adjacent to the tissuemass so that the fiducial sensor is in contact with the tissue mass orso that the fiducial sensor is slightly spaced from the tissue mass).

FIG. 7 is a partial perspective view of a conventional stapler deviceused for resecting a tissue mass.

FIG. 8 is a partial perspective view of the stapler device of FIG. 7with a sleeve including an instrument sensor over a housing of thestapler device according to one embodiment of the present invention.

FIG. 9 is a perspective view of the stapler device of FIG. 8 insertedinto a patient and shows a distance between the fiducial sensor and theinstrument sensor.

FIG. 10 is an example screenshot of a virtual endoscopy or “scope” viewof a tissue mass overlaid on a laparoscopy view.

FIG. 11 is an example screenshot of a laparoscopy view of a tissue mass.

FIG. 12 is a schematic view showing the tree-like structure of theairways of the lung.

FIGS. 13, 13A and 13B are schematic views showing how a bronchoscope canbe used to position a tracked catheter (i.e., a catheter carrying asensor) in a specific airway of the lung, whereby to identify thatspecific airway of the lung, and how a surgical instrument carryinganother sensor can be guided relative to that airway (e.g., to targetthat airway, to avoid that airway, etc.).

FIGS. 14-35 are schematic views showing how a tracked catheter can beused to identify the location of an airway.

FIGS. 36 and 37 are schematic views showing another way that a trackedcatheter can be used to identify the location of an airway.

FIG. 38 is a schematic view showing an anatomical site containing alesion, a fiducial sensor and a tracked catheter.

FIG. 39 is a schematic view showing a fiducial sensor deployed using apercutaneous access.

FIGS. 40 and 41 are schematic views showing a wireless fiducial sensordeployed through a bronchoscope.

FIG. 42 is a schematic view showing a wire-based fiducial sensordeployed through a bronchoscope and having its wire then pushedbronchoscopically, under image guidance, through the lung parenchyma tothe surface of the skin.

FIG. 43 is a schematic view showing a wire-based fiducial sensordeployed through a bronchoscope and having its wire thereafter detachedfrom the fiducial sensor and withdrawn up the airway.

FIGS. 44-46 are schematic views showing apparatus for another approachfor bronchoscopic deployment of the fiducial sensor into tissue (e.g.,bronchoscopic deployment of the fiducial sensor into the tissue mass oradjacent to the tissue mass).

FIGS. 46A and 46B are schematic views showing another apparatus forbronchoscopic deployment of the fiducial sensor into tissue (e.g.,bronchoscopic deployment of the fiducial sensor into the tissue mass oradjacent to the tissue mass).

FIGS. 47-52 are schematic views showing how the apparatus of FIGS. 44-46may be used for bronchoscopic deployment of the fiducial sensor intotissue (e.g., bronchoscopic deployment of the fiducial sensor into thetissue mass or adjacent to the tissue mass).

FIG. 52A is a schematic view showing how a temporary proximal electricalconnection may be provided for the fiducial sensor, e.g., such as whenthe fiducial sensor is deployed through a bronchoscope.

FIGS. 53 and 54 are schematic views showing a surgical stapler with anarticulation sensor for detecting the articulation of the head of thesurgical stapler.

FIGS. 55 and 56 are schematic views showing (i) a model of a lesion, and(ii) a model of a resection margin in combination with a model of alesion.

FIGS. 57-60 are schematic views showing how staples may be deployedadjacent to the resection margin of a lesion.

DETAILED DESCRIPTION OF THE INVENTION

Before any embodiments of the invention are explained in detail, it isto be understood that the invention is not limited in its application tothe specific details of construction and the arrangement of componentsset forth in the following description or illustrated in the followingdrawings. The invention is capable of other embodiments and of beingpracticed or of being carried out in other ways. Also, it is to beunderstood that the phraseology and terminology used herein is for thepurpose of description and should not be regarded as limiting. The useherein of “including,” “comprising,” or “having” and variations thereofis meant to encompass the items listed thereafter and equivalentsthereof as well as additional items. Unless specified or limitedotherwise, the terms “mounted,” “connected,” “supported,” and “coupled”and variations thereof are used broadly and encompass both direct andindirect mountings, connections, supports, and couplings. Further,“connected” and “coupled” are not restricted to physical or mechanicalconnections or couplings.

The following discussion is presented to enable a person skilled in theart to make and use embodiments of the invention. Various modificationsto the illustrated embodiments will be readily apparent to those skilledin the art, and the generic principles herein can be applied to otherembodiments and applications without departing from the scope of thepresent invention. Thus, embodiments of the invention are not intendedto be limited to the specific embodiments shown, but are to be accordedthe widest scope consistent with the principles and features disclosedherein. The following detailed description is to be read with referenceto the figures, in which like elements in different figures have likereference numerals. The figures, which are not necessarily to scale,depict selected embodiments and are not intended to limit the scope ofthe present invention. Skilled artisans will recognize the examplesprovided herein have many useful alternatives and fall within the scopeof embodiments of the invention.

Tracking the Location of a Tissue Mass Using Fiducial Sensors

FIGS. 1-3 illustrate an exemplary fiducial sensor 10 (also sometimesreferred to as a fiducial marker or a fiducial tracker) being insertedthrough a delivery needle 12. The fiducial sensor 10 may be, forexample, a marker that includes a transmitter that measures position andorientation of a tissue mass 18 in real-time. The fiducial sensor 10 maybe attached to a cable 14, as shown in FIGS. 1-3 , or the fiducialsensor 10 may be wireless. The fiducial sensor 10 may be embedded withina hook structure 16, as shown in FIG. 1 . The hook structure 16 of thefiducial sensor 10 can be made from a superelastic material, for examplenitinol, or stainless steel, or any other suitable material. This willallow for the fiducial sensor 10 to be inserted through the deliveryneedle 12 and deployed through an opening 22 (i.e., the lumen) of thedelivery needle 12 into the center of or at the periphery of the tissuemass 18. The tissue mass 18 may be, for example, a lesion (e.g., atumor, a nodule, etc.).

As shown in FIG. 4 , a more detailed view of the fiducial sensor 10 andhook structure 16 is shown. The hook structure 16 may include a tubeportion 15 having a plurality of extensions 17 extending from one end ofthe tube portion 15 and a plurality of prongs 20 extending from anopposing end of the tube portion 15. The tube portion 15 may be, forexample, a nitinol tube having an outer diameter D₁ between about 0.6millimeters and about 0.8 millimeters, and the hook structure 16 mayhave an overall length L between about 8 millimeters and about 12millimeters. The tube portion 15 may be laser micro-machined into acylindrical shape having the plurality of extensions 17 extendingtherefrom to secure the fiducial sensor 10 in place. In someembodiments, the fiducial sensor 10 may be an electromagnetic sensorthat is attached to the proximal end of the hook structure 16 using amedical grade epoxy adhesive, such as AA-Bond FDA22.

The plurality of prongs 20, as shown in FIG. 4 , may be configured toanchor the hook structure 16, including the fiducial sensor 10, into atissue mass or at the periphery of a tissue mass, such as the tissuemass 18 of FIG. 2 . The plurality of prongs 20 may be constructed from asuperelastic shape memory alloy, such as nitinol. The plurality ofprongs 20 may be bent, for example, and extend outwardly from a centralaxis Y of the hook structure 16. The plurality of prongs 20 may also beheat-treated to ensure that the prongs 20 retain the curved shape andthe phase structure of the nitinol is in the Martensite phase, forexample. In the embodiment shown in FIG. 4 , the hook structure 16includes three prongs 20, however, any suitable number of prongs may beprovided in order to anchor the hook structure 16 to the tissue mass orat the periphery of a tissue mass, such as the tissue mass 18.

The fiducial sensor 10 along with the hook structure 16 may be insertedthrough a distal end of the delivery needle 12, which may be an 18-gaugeneedle, for example. The plurality of prongs 20 of the hook structure 16may be inserted into the lumen 22 of the delivery needle 12 first.Advantageously, due to the superelastic nature of nitinol, the hookstructure 16 can be easily inserted into the lumen 22 of the deliveryneedle 12. The hook structure 16 may be deployed using a metal stylet(not shown) that is inserted through the lumen 22 of the delivery needle12. Upon being completely deployed, the plurality of prongs 20 willregain their original curved shape and open up to firmly anchor the hookstructure 16 into or at the periphery of the tissue mass 18. Thedelivery needle 12 may then be removed after deployment of the hookstructure 16.

In some embodiments, the fiducial sensor 10 along with the hookstructure 16 may be inserted through the delivery needle 12 underreal-time image guidance (e.g., CT, C-arm CT, MRI, Ultrasound, etc.) andembedded within the tissue mass 18, as shown in FIG. 5 , or next to thetissue mass 18 (e.g., in close proximity to), as shown in FIG. 6 . Thefiducial sensor 10 may be embedded within or next to the tissue mass 18before or during a surgical procedure. By using real-time imageguidance, the spatial relationship (i.e., position and orientation) ofthe fiducial sensor 10 to the tissue mass 18 in three dimensions isknown at all times. The hook structure 16 may be in the form of a T-baror J-bar, for example, to anchor the fiducial sensor 10 within or nextto the tissue mass 18 to inhibit migration. Advantageously, the force isat the center of the T-bar 16 due to the wire 14, thereby facilitatinganchoring the fiducial sensor 10 within or next to the tissue mass 18.The fiducial sensor 10 embedded within or next to the tissue mass 18will measure the position and orientation of the tissue mass 18 inreal-time in spite of any deformation introduced due to soft tissuedeformation or physiological motion such as collapsing of the lung orrespiration, for example, thereby easily identifying the location of thetissue mass 18 that is often difficult to determine.

In an alternative embodiment, shown in FIG. 3 , a second fiducial sensor11 (in the form of a T-bar assembly, for example) may be put in adifferent location near the tissue mass 18. The second fiducial sensor11 may have a separate cable 14 from the first fiducial sensor 10, asshown in FIG. 3 , or the first fiducial sensor 10 and the secondfiducial sensor 11 may share the same cable 14. The second fiducialsensor 11, or any other such device, can be used to improve thelocalization of the tissue mass 18, even when there may be deformation.For example, the second fiducial sensor 11 can be placed on the oppositeside of the tissue mass 18 from the first fiducial sensor 10 and berecognized by the first fiducial sensor 10 through distortions in theelectromagnetic field. Therefore, by knowing that the tissue mass 18 isbetween these two sensors, the tissue mass 18 can be localized despitechanges in the soft tissue.

Referring now to FIGS. 5 and 6 , once the position and orientation ofthe tissue mass 18 is known, a resection margin 24 having apredetermined distance D₂ surrounding the tissue mass 18 is determinedby creating a three dimensional envelope around the tissue mass 18. Theresection margin 24 may be manually set to the desired predetermineddistance D₂, for example, two centimeters, and is dependent on thesurgeon’s preference and the lesion type. The predetermined distance D₂defines a threshold value so when a surgical device 26 (e.g., a surgicalstapler), described in further detail below, is in a position less thanthe threshold value, auditory, visual and/or haptic cues may be providedto the surgeon or to the surgical device 26 to ensure precise andcomplete resection of the tissue mass 18.

Tracking the Location of A Surgical Device Using an Instrument Sensor

Referring now to FIG. 7 , a conventional surgical device 26, such as asurgical stapler, Bovi pencil, kitner, laparoscope and/or any suitablecutting, resecting or ablating device, is shown. The surgical device 26may include a handle 30 coupled to a fastening assembly 32 at anopposite end of the surgical device 26. The fastening assembly 32 may bea single-use component that is removably connected to the handle 30,i.e., the fastening assembly 32 may be a cartridge that connects to thehandle 30 and is removed after use. The fastening assembly 32 includes ahousing 34 that contains a plurality of fasteners 36 that are secured totissue during resection of the tissue mass 18. The fastening assembly 32may also include a blade slot 38 that accommodates a blade (not shown)for cutting along the resection margin 24 of the tissue mass 18.

In a preferred embodiment, the surgical device 26 includes a sleeve 40that is dimensioned to slide over the housing 34, for example, as shownin FIG. 8 . The sleeve 40 may be any commercially available sleeve, forexample, that is configured to go over the housing 34 of the surgicaldevice 26. An instrument sensor 28 (sometimes referred to as aninstrument tracker) may be attached, by stitching for example, to thesleeve 40. Alternatively, the instrument sensor 28 may be attacheddirectly to the housing 34 of the surgical device 26 via any suitableadhesive or integrated within the housing 34 itself. Regardless of wherethe instrument sensor 28 is attached, either the sleeve 40 or thehousing 34, the instrument sensor 28 can measure the position andorientation of the surgical device 26 in the same imaging referenceframe as the fiducial sensor 10 embedded within or next to the tissuemass 18. In other words, the position of the surgical device 26 may beprecisely measured with respect to the fiducial sensor 10 which iswithin or next to the tissue mass 18, as will be described in furtherdetail below. Since both the fiducial sensor 10 and the instrumentsensor 28 are measured in the same reference frame, errors introduceddue to the registration and calibration steps, requiring a change ofreference axis, can be minimized.

The sleeve 40 may also include a display 42 that shows the user adistance D₃, shown in FIG. 9 , of the surgical device 26 from theresection margin 24, as will be described below. The display 42 may beattached to the handle 30 of the surgical device 26 and could be anycommercially available organic light-emitting diode (OLED) display orliquid-crystal (LCD) display. In the case of an OLED display, areformatted CT image of the tissue mass 18 located at the tip of thesurgical device 26, for example, may be displayed to the user.

Guiding the Surgical Device to the Tissue Mass

Referring now to FIG. 9 , during operation, the fiducial sensor 10 ispositioned next to or embedded within the tissue mass 18 using theplurality of prongs 20 of the hook structure 16, as previouslydescribed. A CT/MRI/fluoroscopic/C-arm CT examination, for example, isperformed to acquire images of the fiducial sensor 10 positioned next toor embedded within the tissue mass 18. The tissue mass 18 is thensegmented from the pre-operative diagnostic CT/MRI examination and athree dimensional model (not shown) of the tissue mass 18 is generated.The intra-operative images obtained during placement of the fiducialsensor 10 may be registered to the patient’s diagnostic exam, and thelocation of the fiducial sensor 10 may be estimated. As previouslydiscussed, the resection margin 24 having the predetermined distance D₂surrounding the tissue mass 18 is displayed to the user on a monitor(not shown) as a three dimensional envelope or proximity sphere aroundthe tissue mass 18. The predetermined distance D₂ of the resectionmargin 24 may be determined based on the surgeon’s preferences and thetype of tissue mass 18.

The surgical device 26 is then inserted into a body 44 (i.e., thepatient), as shown in FIG. 9 , to cut the tissue mass 18 along theresection margin 24. The fiducial sensor 10 embedded within or close tothe tissue mass 18 is in electrical or wireless communication with acontroller 48. The controller 48 may be a programmable logic controller(PLC) and is configured to interpret a signal generated by the fiducialsensor 10. The fiducial sensor 10 may be an electromagnetic sensor, forexample, that generates a signal indicative of the position andorientation (e.g., one or more spatial coordinates) of the fiducialsensor 10. The signal generated by the fiducial sensor 10 may be, forexample, an electrical signal and the controller 48 may interpret thissignal via a stored program 50. The stored program 50 may include, forexample, a navigation system that is in communication with the fiducialsensor 10 and the instrument sensor 28.

Similarly, the instrument sensor 28 may be an electromagnetic sensor,for example, that generates a signal indicative of the position andorientation (e.g., one or more spatial coordinates) of the instrumentsensor 28. The signal generated by the instrument sensor 28 may be, forexample, an electrical signal and the controller 48 may interpret thissignal via a stored program 50. The fiducial sensor 10 and theinstrument sensor 28 communicate with the controller 48 and relay theposition and orientation of the tissue mass 18 and the surgical device26 using the navigation system. In some embodiments, the stored program50 may be configured to run calibration and/or registration algorithmsto track the distal tip of the surgical device 26 and the normal vectorto the surgical device 26. Thereafter, the stored program 50 of thecontroller 48 calculates the distance D₃, shown in FIG. 9 , between thefiducial sensor 10 and the instrument sensor 28 such that when thesurgical device 26 is below a threshold value of D₃, an auditory, visualor haptic cue is generated for the user.

As the surgical device 26 is navigated towards the resection margin 24of the tissue mass 18, the surgical device 26 may excise the tissue mass18 while minimizing damage to surrounding tissue due to both thefiducial sensor 10 and instrument sensor 28 being actively tracked.Minimal damage to the surrounding healthy tissue may also ensure normalphysiological function, for example, lung function. Utilizing feedbackfrom the fiducial sensor 10 and the instrument sensor 28 on the surgicaldevice 26, the distance D₃ from the tissue mass 18 and the surgicaldevice 26 may be known to the user and visible on the display 42 at alltimes. As a result, the desired resection margin 24 may be maintained atall times, thereby ensuring complete resection of the tissue mass 18. Inone embodiment, the position and orientation data of the tissue mass 18and the surgical device 26 may be used to lock or unlock the surgicaldevice 26 to inhibit erroneous resection of the tissue mass 18.

Tissue Deformation Algorithms

In some embodiments, the stored program 50 of the controller 48 may beconfigured to include one or more deformation algorithms that estimateor model changes that can occur to the resection margin 24 during aprocedure, as a result of deformations of the tissue mass 18 and/or thesurrounding tissue. The deformation algorithms attempt to account forany such changes to the resection margin 24 to provide more accurateresection margins to a user during a procedure, which aids in completeresection of the tissue mass 18 while limiting damage to, or removal of,healthy surrounding tissue.

In one non-limiting example, the stored program 50 includes adeformation algorithm that assumes that the tissue mass 18 (e.g., abreast lesion) is rigid and that the surrounding tissue (e.g., theparenchyma) deforms. The algorithm assumes every point on the tissuemass 18 moves along with the fiducial sensor 10, which is anchored tothe tissue mass 18 as described above. In another non-limiting example,the stored program 50 includes a deformation algorithm that assumes thetissue mass 18 is a rigid object moving through a viscoelastic or fluidmedium. In yet another non-limiting example, patient-specific propertiesof the tissue mass 18 and the surrounding tissue can be measured, forexample, via a CT/MRI/fluoroscopic examination, to predict deformationsto tissue mass 18 or resection margin 24 that occur during an operationfor that specific patient. It should be appreciated that the deformationalgorithms of the stored program 50 may operate on a real-time basiswith the navigation system of the stored program 50.

More specifically, a tissue mass 18 (e.g., a lesion) can be segmentedfrom volumetric images obtained, for example, from theCT/MRI/fluoroscopic examination, to create a surface model. Based upon adefault resection margin inputted into the navigation system by a user,a segmented lesion label map can be dilated to the desired resectionmargin to create a surface model corresponding to the resection margin.Due to deformation of the lesion and the surrounding tissue, theresection margin can change, for example, due to movement of thepatient. A linear elastic volumetric finite element model (“FEM”) meshcan therefore be created from the surface model of the lesion and theresection margin. Using the FEM model, an estimate of the displacementof the other nodes of tissue mass 18 and resection margin 24 can bemade, given the real-time position measurement of the fiducial sensor10. Stiffness values may not be entirely accurate for the FEM model, andthe FEM model may be constrained in one example to the tissue mass 18and the surrounding tissue. Uncertainty measurements of the tissue mass18 and the surrounding tissue deformation can therefore be provided to auser in real-time based upon the uncertainty in the estimated stiffnessvalues of the FEM mesh.

Auditory, Visual, Quantitative and Haptic Cues

As described above, auditory, visual and haptic cues may be provided tothe surgeon and/or the surgical device 26 to identify the resectionmargin 24 to ensure precise and complete resection of the tissue mass18. For example, an audible source 52 may be configured to emit anaudible signal. The audible source 52 may be in communication with thecontroller 48 that is configured to execute the stored program 50 toalter the audible signal based on the distance D₃ between the instrumentsensor 28 and the fiducial sensor 10. The instrument sensor 28 uses thesignal generated by the fiducial sensor 10 to enable the controller 48to execute the stored program 50 to calculate the distance D₃, shown inFIG. 9 , between the fiducial sensor 10 and the instrument sensor 28such that when the surgical device 26 is below a threshold value of D₃,the audible signal is generated. The audible signal may be, for examplea tone, beep or alarm. The audible signal may also increase in frequencyor duty cycle as the distance D₃ decreases, such that as the surgicaldevice 26 is navigated too close to the resection margin 24, the audiblesignal’s frequency or duty cycle increases.

In addition to the auditory cues, visual cues may also be provided tothe user on one or more displays 54 in communication with the controller48. The one or more displays 54 may include, for example, visual cuesprovided on an endoscopic display or a separate monitor. For example,the endoscopic display or the separate monitor may be configured to emita visual signal. The endoscopic display or the separate monitor may bein communication with the controller 48 that is configured to execute astored program 50 to alter the visible signal based on the distance D₃between the instrument sensor 28 and the fiducial sensor 10. Theinstrument sensor 28 uses the signal generated by the fiducial sensor 10to enable the controller 48 to execute the stored program 50 tocalculate the distance D₃, shown in FIG. 9 , between the fiducial sensor10 and the instrument sensor 28 (e.g., near the tip of the surgicaldevice 26), and/or between the instrument sensor 28 (e.g., near the tipof the surgical device 26) and a vector normal to the hook structure 16,such that when the surgical device 26 is below a threshold value of D₃,the visual signal is generated. The visual signal may be, for example, asolid or flashing light shown on the one or more displays 54, such asthe endoscopic display or the separate monitor. The visual signal mayalso increase in frequency or brightness, for example, as the distanceD₃ decreases, such that as the surgical device 26 is navigated too closeto the resection margin 24, the visual signal’s frequency and/orbrightness increases. Further, the distances from the tip, mid or baseof the cutting surface of the instrument can also be determined based ona stored program and displayed to the user. Such a display of distancenumerics may sometimes be referred to herein as a so-called quantitativecue.

In one non-limiting example, the visual cue may be shown as a colorchanging sphere, for example, on one of the displays 54. The colorchanging sphere may be representative of the tissue resection margin 24,for example, such that the color changes based on the distance D₃between the instrument sensor 28 and the fiducial sensor 10. Thus, asthe instrument sensor 28 approaches the fiducial sensor 10, for example,the sphere may be shown in the display 54 in a first color. Likewise, asthe instrument sensor 28 moves away from the fiducial sensor 10, thesphere may be shown on the display 54 in a second color, for example,thereby allowing the surgeon to appreciate, visually, the distance D₃between the instrument sensor 28 and the fiducial sensor 10.

Although quantitative, visual, and auditory cues may be provided to theclinician to identify the distance of the resection margin 24 from thesurgical instrument 26, the visual cue may further include a videooverlay provided to the user on one or more of the displays 54 incommunication with the controller 48. For example, a video overlay maybe implemented to fuse the laparoscopy images and virtual endoscopyimages to confirm the position of the fiducial sensor 10 and the tissuemass 18, as shown on the display 54 of FIG. 10 . Based on the positionof the laparoscope 56, as shown on the display 54 of FIG. 11 , thevirtual endoscopy video of the three dimensional anatomy can begenerated. The focal length and field of view may be inputted to controlthe virtual endoscopy view generated using a visualization toolkitcamera, for example, of the three dimensional view.

Haptic cues may also be provided to the user on the surgical device 26.For example, a piezoelectric actuator 46 may be attached to the handle30 of the surgical device 26 that is configured to emit a haptic signal.The piezoelectric actuator 46 may be in electrical communication withthe controller that is configured to execute a stored program to alterthe haptic signal based on the distance D₃ between the instrument sensor28 and the fiducial sensor 10. The instrument sensor 28 uses the signalgenerated by the fiducial sensor 10 to enable the controller to executethe stored program to calculate the distance D₃, shown in FIG. 9 ,between the fiducial sensor 10 and the instrument sensor 28 such thatwhen the surgical device 26 is below a threshold value of D₃, the hapticsignal is generated. The haptic signal may be, for example a vibrationapplied to the handle 30 of the surgical device 26. The haptic signalmay also increase in amplitude and/or frequency, for example, as thedistance D₃ decreases, such that as the surgical device 26 is navigatedtoo close to the resection margin 24, the haptic signal’s amplitudeand/or frequency increases.

Application to Lung Cancer Surgery

Nearly 230,000 new cases of lung cancer are diagnosed each year in theUnited States, at an estimated cost of $12.1 billion to the healthcaresystem. Patients with lung cancer have 1-year and 5-year survival ratesof 44% and 17%, respectively. For treatment of early stage smalllesions, a parenchymal-sparing, minimally invasive Wedge ResectionSurgery (WRS) or segmentectomy is becoming the preferred method ofsurgical resection over lobectomy. The preservation of healthy lungfunction becomes even more important when the lung physiology iscompromised due to excessive smoking, old age, multiple lesions,previous lung surgery, cardiac comorbidity or Chronic ObstructivePulmonary Disease (COPD). Although these approaches (i.e., WRS andsegmentectomy) result in better lung function, the lesion recurrencerate is almost double that of a lobectomy, with significantly poorer5-year survival rates. In addition, segmentectomy is associated withsignificant complications. The loco-regional recurrence andcomplications associated with segmentectomy may be attributed to thedifficulty in accurately localizing and resecting the lesions in adeflated lung, and the difficulty in identifying the intersegmentalplane. To avoid peri- and post-operative complications, precise anatomiclandmarks (e.g., vascular and bronchial anatomic variations) need to becarefully identified and followed.

In the preceding sections, it is taught that a fiducial sensor 10 (e.g.,a T-bar or J-bar assembly) is placed close to the lesion 18 in order totrack the lesion in real-time. The surgical stapler (or other surgicaldevice) 26 is also tracked in real-time using an instrument sensor 28 toprecisely guide the resection of the lung lesion 18. More particularly,navigation software computes the distance of the surgical stapler to thefiducial sensor (e.g., the T-bar or J-bar assembly), 26 and hence thedistance of the surgical stapler 26 to the lesion 18, and displays thedistance measurement to the surgeon in real-time so as to ensurecomplete lesion resection. Further, the distances of the fiducial sensor10 or the tumor surface to the tip, middle and base of the staplercutting line (also sometimes referred to herein as a resection line) canalso be computed and displayed in real-time.

Using The System to Identify a Specific Airway in the Lung So as toAssist a Surgeon in Identifying That Airway During Surgery From theChest Side of the Operation

The system can also be used to identify a specific airway in the lung soas to assist a surgeon in identifying that airway during surgery fromthe chest side of the operation.

More particularly, the airways of the lung have a complex tree-likestructure. See FIG. 12 .

When treating a lesion in the lung, and particularly where the treatmentmay involve a resection of the lung in order to remove the lesion, itcan be important to plan the resection relative to specific airways,i.e., to remove a specific airway, to avoid a specific airway, etc.Therefore, it can be important to know the location of relevant airwayswhen conducting the resection surgery.

During bronchoscopy, it is possible to identify the location of thebronchoscope relative to specific airways, since the bronchoscopefollows a descending path characterized by specific branching as thebronchoscope proceeds down the tree-like structure of the airways.However, the bronchoscope can typically traverse only a limited distancedown the airways of the lung given its size and the progressivelydecreasing size of the airways. Furthermore, during surgery from thechest side of the operation, the visualization provided to the surgeonfrom the chest side is limited to a direct field of view and it can behighly problematic to identify, from the chest side, a specific airwaydue to the limited view provided to the surgeon from the chest side.

The present invention can be used to identify a specific airway in thelung so as to assist a surgeon in identifying that airway during surgeryfrom the chest side of the operation.

More particularly, and looking now at FIGS. 13, 13A and 13B, in thisform of the invention, a bronchoscope 60 is used to position a catheter65 carrying a sensor 70 (i.e., a “tracked catheter” 75) into a relevantairway of the lung. More particularly, in one preferred form of theinvention, the bronchoscope 60 can be advanced through the airways underbronchoscopic guidance or by some other form of guidance, e.g., CTimaging, C-arm imaging, etc. until the bronchoscope 60 is advanced asfar as possible toward the relevant airway. See FIG. 13 . Then a trackedcatheter 75 (i.e., a catheter 65 carrying a sensor 70) is advanced downthe bronchoscope 60 and then out the end of the bronchoscope 60 into therelevant airway of the lung. See FIG. 13A. Note that, preferably, thetracked catheter 75 is not advanced through the bronchoscope 60 untilafter the bronchoscope 60 has been positioned in the lung in order tomaintain maximum flexibility for the bronchoscope 60. Once the trackedcatheter 75 has been advanced out the bronchoscope 60 and into positionin the relevant airway, the bronchoscope 60 can be withdrawn. See FIG.13B. Withdrawal of the bronchoscope 60 is generally desirable at thispoint since it can impede ventilation.

The bronchoscopic positioning of a sensor in a relevant airway of thelung (i.e., by bronchoscopically positioning a tracked catheter in arelevant airway of the lung) can then be used to define the lobar,segmental or subsegmental bronchus for surgery such as segmentectomy,lobectomy or wedge resection during the actual operation. Moreparticularly, the position of the sensor identifying the bronchus (i.e.,the sensor 70 on the tracked catheter 75) can be correlated with theposition of another device (e.g., a surgical instrument) 80 carryinganother sensor 85 (i.e., a tracked instrument 90) so that the surgeoncan use the system to identify the correct bronchus for surgery from thechest side of the operation (when direct visualization is limited andfrequently ambiguous with respect to specific airways). Thus, in thisform of the invention, one sensor 70 is positioned on a catheter 65which is inserted into a specific airway so as to identify the locationof that specific airway, and another sensor 85 is positioned on asurgical instrument 80 which is advanced for surgery from the chest sideof the operation, and the system then tracks the position of thesurgical instrument 80 vis-à-vis the tracked catheter 75 (and hencevis-à-vis the position of the airway in which the tracked catheter 75 ispositioned). In this way, the surgeon can identify the location of thesurgical instrument 80 relative to the airway of interest (which isidentified by the sensor 70 on the tracked catheter 75), even thoughdirect visualization from the chest side of the operation may be limitedand ambiguous with respect to specific airways. As a result, the surgeoncan use the system to target the airway identified by the sensor 70 onthe tracked catheter 75, or to avoid the airway identified by the sensor70 on the tracked catheter 75, etc.

Significantly, the tracked catheter 75 may be inserted into a relevantairway of the lung while the lung is in a first configuration (e.g., aninflated configuration) and maintained in position within that airwaywhile the lung transforms to a second configuration (e.g., a deflatedconfiguration). This can be particularly advantageous when trying toidentify a relevant airway of the lung during a limited access surgicalprocedure (e.g., where visualization is provided by a scope advancedinto the chest) and the lung transforms between a first configurationand a second configuration.

Note that, if desired, the tracked catheter 75 may be inserted into thebronchoscope 60 before the bronchoscope 60 is advanced down the airwaysof the lung. However, as noted above, it is generally desirable toinsert the tracked catheter 75 into the bronchoscope 60 after thebronchoscope 60 has been positioned in the lung since this providesmaximum flexibility to the bronchoscope 60.

Note also, if desired, the bronchoscope 60 may be left in position inthe lung after the tracked catheter 75 has been advanced into therelevant airway. However, as noted above, in many cases it is desirableto remove the bronchoscope 60 after the tracked catheter 75 has beenadvanced into the relevant airway since this provides better ventilationof the lung.

In addition to the foregoing, it should also be appreciated that, ifdesired, the bronchoscope 60 itself can carry a sensor (not shown), suchthat the bronchoscope 60 itself can be tracked in the airways of thelung. This approach can be useful where the bronchoscope 60 is able toadvance into the airway of interest, e.g., where the airway of interestis a relatively large airway which can be directly accessed by thebronchoscope 60.

Note that, if desired, the tracked catheter 75 (and/or a trackedbronchoscope) may also be used to map a plurality of airways in the lungwhile the lung is in a given configuration (e.g., a first, inflatedconfiguration).

In one form of the invention, a fiducial sensor 10 (e.g., a T-bar orJ-bar assembly) is placed within the lung while the lung is in a first(e.g., inflated) configuration; a tracked catheter 75 is placed in aselected airway of the lung while the lung is in its first (e.g.,inflated) configuration; the relative dispositions of the fiducialsensor 10 and the tracked catheter 75 are determined while the lung isin its first (e.g., inflated) configuration; the lung is transformed toa second (e.g., deflated) configuration; the relative dispositions ofthe fiducial sensor 10 and the tracked catheter 75 are determined whilethe lung is in its second (e.g., deflated) configuration; and the changein the relative dispositions of the fiducial sensor 10 and the trackedcatheter 75 is determined after the lung transforms from its first(e.g., inflated) configuration to its second (e.g., deflated)configuration and used to estimate the extent of lung deformation andthe location of lung structures when the lung is in its second (e.g.,deflated) configuration.

Mapping and Tracking of the Surrounding Airways

The foregoing system can be enhanced by mapping and tracking thesurrounding airways (along with the lesion) so as to ensure that thecorrect segment of the lung is excised. This is because during deflationof the lung, the anatomy will shift and the tissue section to be excisedmay not be obvious to the surgeon.

The procedure for mapping and tracking the airways of the lung may bedone as follows.

First, the patient is placed in the supine position. Then,bronchoscopically, a flexible catheter 65 having an on-board cathetersensor 70 is placed in the nearest/target bronchus of the lung segmentcontaining the lesion 18. This is done either by identifying the correctbronchus visually or by some form of guidance (e.g., CT imaging, C-armimaging, etc.). The tracked catheter 75 is inserted into the targetedbronchus near to the mass of the lesion 18, and as the catheter 65 isinserted, the trajectory of the catheter 65 is logged using the on-boardcatheter sensor 70 and an electromagnetic tracker system configured toidentify the position and orientation of the catheter sensor 70 (andhence the position and orientation of the catheter 65). This trajectorymarks the position of the airway 95 in the coordinate space of theelectromagnetic tracker system. See FIGS. 14-34 . The successivedetected locations of the catheter sensor 70 as the catheter 65 advancesdown the airway 95 can be concatenated so as to provide the centerlineof the targeted airway. See FIG. 35 .

Alternatively, the catheter 65 can comprise a plurality of cathetertrackers 70 located along its length so that airway mapping can beconducted by simply logging the locations of the various cathetersensors 70 after the catheter 65 has been fully inserted in an airway.See FIGS. 36 and 37 . Note that the catheter 65 can be advanced throughthe airways under bronchoscopic guidance or by some other form ofguidance, e.g., CT imaging, C-arm imaging, etc.

The process can then be repeated with adjacent airways so as to map outthe airways surrounding the lesion.

Once the mapping of the relevant airways has been completed, theposition of the fiducial sensor 10 (e.g., the T-bar or J-bar assembly orsimilar tracker) and mapped airways are recorded in the inflated lung(and, ultimately, in the deflated lung).

Thereafter, with a fiducial sensor 10 next to the lesion 18 and thetracked catheter 75 disposed in a critical airway near the lesion, thelung is collapsed prior to the start of the surgery. The fiducial sensor10 (e.g., the T-bar or J-bar assembly) and the tracked catheter 75 aretracked in real-time as the lung is collapsed. See FIG. 38 . Theposition of the fiducial sensor 10 (e.g., the T-bar or J-bar assembly)and the critical airway (e.g., the airway containing the trackedcatheter 75) is recorded in the deflated lung. Using a finiteelement-based particle filter or FEM deformation algorithm, the spatialtranslation of the fiducial sensor 10 (e.g., the T-bar or J-barassembly) and the critical airway from the inflated condition to thedeflated condition is estimated. A smooth deformation field around thecritical airway is estimated. The deformation field is then applied tothe other airways mapped in the inflated lung so as to estimate theposition of those other airways in the deflated lung. The “deformed”airways (i.e., the airways in the deflated lung) are displayed to thesurgeon in the navigation system, along with the lesion, to preciselyguide the surgical stapler 26 to the optimal resection margin whileensuring that critical anatomy is spared. This approach also, evenwithout stapler navigation, helps define the correct segment forresection (as well as the correct bronchial segment to resect or notresect as part of the planned operation). Once the appropriate bronchialsegment is identified in the thoracoscopic, or thoracic point of view,the catheter 65 may be removed prior to any surgical resection, bysimply pulling it out of the airway from the mouth, nose or endotrachealtube.

In one aspect of the invention, a plurality of lumens in a deformableanatomical structure may be mapped and tracked by:

-   providing a virtual model of the anatomical structure while the    anatomical structure is in a first configuration;-   while the anatomical structure is in the first configuration,    positioning a tracked catheter in one of the lumens in the    anatomical structure which is to be mapped and tracked, and    determining the position of the tracked catheter in that lumen so as    to map the position of that lumen;-   repeating the foregoing step for each of the lumens in the    anatomical structure which is to be mapped and tracked so that those    lumens are mapped;-   supplementing the virtual model with the mapped lumens, whereby to    provide a supplemented virtual model of the anatomical structure and    the mapped lumens while the anatomical structure is in its first    configuration;-   maintaining the tracked catheter in one of the mapped lumens of the    anatomical structure as the anatomical structure is deformed from    its first configuration to a second configuration;-   determining the position of the tracked catheter in the anatomical    structure while the anatomical structure is in the second    configuration; and-   modifying the supplemented virtual model so as to represent the    anatomical structure and the mapped lumens while the anatomical    structure is in its second configuration, whereby to provide a    modified supplemented virtual model, wherein modification is    effected by:    -   determining the spatial transformation of the tracked catheter        as the anatomical structure deforms from its first configuration        to its second configuration; and    -   applying the spatial transformation of the tracked catheter to        the mapped lumens of the supplemented virtual model so as to        provide the modified supplemented virtual model of the        anatomical structure and the mapped lumens while the anatomical        structure is in its second configuration.

In another aspect of the invention, a selected lumen in a deformableanatomical structure may be mapped and tracked by:

-   positioning a tracked catheter in the selected lumen of the    anatomical structure while the anatomical structure is in a first    configuration;-   determining the position of the tracked catheter while the    anatomical structure is in the first configuration;-   scanning the anatomical structure and the tracked catheter    positioned in the selected lumen of the anatomical structure while    the anatomical structure is in the first configuration;-   creating a virtual model of the scanned anatomical structure and the    tracked catheter positioned in the selected lumen of the anatomical    structure while the anatomical structure is in its first    configuration;-   maintaining the tracked catheter in position within the selected    lumen of the anatomical structure while the anatomical structure    deforms to a second configuration;-   determining the position and orientation of the tracked catheter    while the anatomical structures is in its second configuration,    whereby to determine the position of the selected lumen of the    anatomical structure while the anatomical structure is in the second    configuration; and-   adjusting the virtual model so as to represent the anatomical    structure and the selected lumen while the anatomical structure is    in its second configuration, whereby to provide an adjusted virtual    model, wherein modification is effected by:    -   determining the spatial transformation of the tracked catheter        as the anatomical structure deforms from its first configuration        to its second configuration; and    -   applying the spatial transformation of the tracked catheter to        the selected lumen of the virtual model so as to provide the        adjusted virtual model of the anatomical structure and the        selected lumen while the anatomical structure is in its second        configuration.

Bronchoscopic Deployment of the Fiducial Sensor

In the system described above, the fiducial sensor 10 (e.g., the T-baror J-bar assembly) is described as being deployed percutaneously. SeeFIG. 39 . However, if desired, the fiducial sensor 10 (e.g., the T-baror J-bar assembly) can be deployed via a bronchoscopic approach, or openchest approach or VATS approach.

More particularly, the fiducial sensor 10 (e.g., the T-bar or J-barassembly) is a metal anchor with a wireless electromagnetic sensorembedded within a hook-like structure. The metal anchor could be madefrom superelastic material, for example nitinol, or it could be madefrom stainless steel. The fiducial sensor 10 (e.g., the T-bar or J-barassembly) is placed within a long flexible hollow tube with a bevel tipat the end. This hollow tube is inserted through the working channel ofthe bronchoscope 60. Under real-time image guidance using the navigationsystem, the wireless fiducial sensor 10 (e.g., the T-bar or J-barassembly) is navigated through the airways using the bronchoscope 60 andplaced close to the lesion. See FIG. 40 . Once the fiducial sensor 10(e.g., the T-bar or J-bar assembly) has been deployed close to thelesion 18, the bronchoscope 60 (and the hollow tube extending throughthe working channel of the bronchoscope) is removed. See FIG. 41 .Thereafter, the lung is collapsed and the lesion 18 is tracked inreal-time using the fiducial sensor 10 (e.g., the T-bar or J-barassembly). The surgical stapler (not shown) is also tracked in real-timeusing the instrument sensor attached to the surgical stapler. Note thatthe surgical stapler is tracked in the same reference frame as thefiducial sensor 10 (e.g., the T-bar or J-bar assembly). The surgicalstapler can then be navigated to the optimal resection margin using thenavigation system.

Alternatively, if desired, the fiducial sensor 10 (e.g., the T-bar orJ-bar assembly) could carry a wire-based electromagnetic sensor. In thiscase, after the fiducial sensor 10 (e.g., the T-bar or J-bar assembly)has been deployed, the wire 14 of the fiducial sensor is then pushedbronchoscopically, under image guidance, through the lung parenchyma tothe surface of the skin at the nearest spot to the lesion 18 so as tomark the lesion 18. See FIG. 42 .

In still another form of the invention, where the fiducial sensor 10(e.g., the T-bar or J-bar assembly) carries a wire-based electromagneticsensor, the wire 14 has a detachable connection to the electromagneticsensor. Then, after the stapler has been used to establish the resectionline, the wire 14 is detached from the electromagnetic sensor and pulledback up the airway. See FIG. 43 .

In yet another form of the invention, and looking now at FIGS. 44-52 , abronchoscopic sensor unit 100 is provided for bronchoscopic deploymentof fiducial sensor 10 into tissue mass 18 or adjacent to tissue mass 18.

More particularly, and looking now at FIGS. 44-46 , bronchoscopic sensorunit 100 (FIG. 44 ) generally comprises a J-bar and electrical leadassembly 105 (FIG. 45 ) and a deployment assembly 110 (FIG. 46 ).

J-bar and electrical lead assembly 105 generally comprises a J-barassembly 115 and an electrical lead 120. J-bar assembly 115 comprisesthe aforementioned hook structure 16 which carries the aforementionedfiducial sensor 10 and the aforementioned prongs 20. One end 125 ofelectrical lead 120 is connected to fiducial sensor 10 such thatelectrical power delivered to electrical lead 120 can power fiducialsensor 10. The other end 130 of electrical lead 120 comprises anatraumatic tip 135. Electrical lead 120 may be covered with ahydrophobic braided wire to allow for easy insertion and retraction ofJ-bar and electrical lead assembly 105 through lumen 150 (see below) ofdeployment assembly 110.

Alternatively, if desired, instead of an atraumatic tip 135, the distalend of J-bar and electrical lead assembly 105 may comprise a secondanchor that could prevent electrical lead 120 from re-entering the lungonce the distal end of electrical lead 120 has emerged from the lung. Inother words, this second anchor would prevent retrograde movement of thedistal end of electrical lead 120 after deployment. Furthermore, in sucha form of the invention, prongs 120 of J-bar assembly 115 could have aconfiguration which prevents antegrade movement of J-bar assembly 115once it is released from deployment assembly 110. See, for example,FIGS. 46A and 46B, which show prongs 135A at the distal end ofelectrical lead 120, and prongs 20A at the distal end of J-bar assembly115, with prongs 135A preventing post-deployment proximal movement ofthe distal end of electrical lead 120 and prongs 20A preventingpost-deployment distal movement of J-bar assembly 115.

Deployment assembly 110 comprises a needle cannula 140 and a pusher 145.Needle cannula 140 comprises a hollow lumen 150 and terminates in asharp tip 155. Pusher 145 comprises a shaft 160. One end of shaft 160ends in a blunt distal end 165. The other end of shaft 160 terminates ina handle 170. Shaft 160 of pusher 145 is sized to be slidably receivedin lumen 150 of needle cannula 140. Note that needle cannula 140 ofdeployment assembly 110 is sized so that it can be inserted through theworking channel of a bronchoscope.

As seen in FIG. 44 , J-bar and electrical lead assembly 105 and shaft160 of pusher 145 are initially disposed within lumen 150 of needlecannula 140, with prongs 20 of J-bar assembly 115 being elasticallydeformed into a straighter configuration so as to be received withinlumen 150 of needle cannula 140, and with the proximal ends of theelastically deformed prongs 20 residing just distal to blunt end 165 ofpusher 145. Note also that when J-bar and electrical lead assembly 105is disposed within lumen 150 of needle cannula 140, atraumatic tip 135of electrical lead 120 is elastically deformed so that it sitssubstantially straight within needle cannula 140 (note that FIG. 44 isintended to be schematic in nature, and in practice electrical lead 120has a diameter which more closely fills lumen 150 of needle cannula 140,such that atraumatic tip 135 of electrical lead 120 sits substantiallystraight when it is confined within needle cannula 140, and returns tothe coiled configuration shown in FIG. 45 when atraumatic tip 135 is notconfined within needle cannula 140). In this way, needle cannula 140 cancarry J-bar and electrical lead assembly 105, with needle cannula 140shielding J-bar and electrical lead assembly 105 from contact withsurrounding structures (e.g., a bronchoscope, tissue, etc.). However,distal movement of pusher 145 can eject J-bar and electrical leadassembly 105 from lumen 150 of needle cannula 140.

In a preferred method of use, the intended position of J-bar andelectrical lead assembly 105 vis-à-vis the anatomy of the patient isplanned prior to deployment in the lung using diagnostic orintraprocedural CT, C-arm CT, MRI or other imaging modalities, i.e., theintended position of J-bar assembly 115, and the exit point ofelectrical lead 120 as it emerges from the lung surface, are planned inadvance on diagnostic or intraprocedural CT, C-arm CT, MRI or otherimaging modalities. The electromagnetic (EM) tracking coordinates aremapped to the diagnostic/intraprocedural imaging coordinates using imageregistration algorithms well known in the art to track the bronchoscopeand J-bar and electrical lead assembly 105 in the imaging coordinates.The position of J-bar assembly 115 is chosen to be in the proximity ofthe tumor, preferably along the line joining the bronchoscope targetposition and the exit position of the electrical lead, while the exitpoint of electrical lead 120 from the lung is chosen to be (i) theshortest path from the J-bar location to the lung surface (or thefissure surface), or (ii) according to surgeon preference.

By way of example but not limitation, in a preferred method of use, andlooking now at FIGS. 47-52 , a bronchoscope 60 is advanced through theairways of the patient until the distal tip of bronchoscope 60 isdisposed near the lesion (i.e., tissue mass) 18. See FIG. 47 . Note thatbronchoscope 60 may be advanced under direct visualization and itsposition may be tracked using one or more sensors 180 carried bybronchoscope 60. Alternatively, the position of bronchoscope 60 may betracked using J-bar assembly 115, provided that a temporary electricalconnection is provided for J-bar assembly 115 (i.e., via an electricalconnection extending through the interior of needle cannula 140, such asby electrifying a portion of pusher 145). The position of the trackedbronchoscope 60 can be mapped to the imaging coordinates (see above)using image registration algorithms of the sort well known in the art inorder to guide the bronchoscope 60 to the lesion 18.

Next, if it has not already been done, a target point 185 is identifiedon the outer surface of the lung as the point where it is desired thatneedle cannula 140 will emerge from the lung and enter the pleuralspace. See FIG. 48 .

Then bronchoscopic sensor unit 100 (comprising deployment assembly 110and its passenger J-bar and electrical lead assembly 105) has its distalend advanced through bronchoscope 60, through the lung, through targetpoint 185 and into the pleural space. See FIG. 49 . Note that the distalend of bronchoscopic sensor unit 100 can be guided visually viabronchoscope 60, and/or via scanner visualization (e.g., CT imaging,C-arm imaging, ultrasound imaging, etc.), or by using thetemporarily-electrically-connected J-bar assembly 115, if a temporaryelectrical connection has been established through the interior ofneedle cannula 140.

Next, pusher 145 of deployment assembly 110 may be used to push J-barand electrical lead assembly 105 distally so that (i) atraumatic tip 135and a portion of electrical lead 120 pass out of needle cannula 140 andinto the pleural space, and (ii) J-bar assembly 115 is disposed adjacentto lesion 18 (note, however, that at this point J-bar assembly 115 and aportion of electrical lead 120 remain within needle cannula 140). SeeFIG. 50 .

Next, needle cannula 140 is retracted proximally while maintainingpusher 145 in position, thereby exposing (i) the portion of electricallead 120 extending from target point 185 to J-bar assembly 115, and (ii)J-bar assembly 115. As needle cannula 140 retracts past prongs 20 ofJ-bar assembly 115, prongs 20 are no longer constrained within lumen 150of needle cannula 140 and are free to spring outboard and set into thetissue, whereby to anchor J-bar assembly 115 (and hence fiducial sensor10) adjacent to lesion 18. See FIG. 51 . At this point, if J-barassembly 115 was temporarily connected to electrical power through theinterior of needle cannula 140, the wires of the J-bar are disconnectedand retracted to within needle cannula 140. Note that this disconnectionand retraction of the electrical leads passing through needle cannula140 is desirable, since it removes them from the intended resectionline.

Then a power supply clamping tool 190 is advanced into the pleural spaceand clamped onto the portion of electrical lead 120 extending out of thelung, whereby to provide electrical power to electrical lead 120 andhence fiducial sensor 10 of J-bar assembly 115. See FIG. 52 . Note thatby supplying electrical power to J-bar assembly 115 via a power supplyclamping tool 190 advanced into the pleural space from a point outsidethe body (rather than through needle cannula 140 and bronchoscope 60advanced through the bronchi), the electrical leads do not cross theintended resection line.

Power supply clamping tool 190 can take various forms. In essence, it isan elongated tool which is configured to extend from outside the bodyinto the pleural space, and to make an electrical connection to theportion of electrical lead 120 extending out of the lung and into thepleural space, whereby to deliver power to J-bar assembly 115. By way ofexample but not limitation, power supply clamping tool 190 may comprisea pair of electrically-connected jaws which can be closed about theportion of electrical lead 120 extending out of the lung and into thepleural space. Note that power supply clamping tool 190 can be deployedeither through a needle extending through the skin or through a portcreated on the skin surface. The power supplied by power supply clampingtool 190 to electrical lead 120 enables J-bar assembly 115 to connect tothe EM tracking system.

Once powered, fiducial sensor 10 communicates with the electromagnetic(EM) tracking system and the location of fiducial sensor 10 (and hencethe location of lesion 18) can be determined by controller 48.

At this point, a surgical instrument 80 (carrying an instrument sensor85) can be used to effect the desired resection line in the lung,whereby to excise lesion 18 from the remainder of the lung. Note thatJ-bar and electrical lead assembly 105 extends from lesion 18 to thepleural space, and hence is contained within the tissue which is beingexcised, and does not cross the resection line. In other words, J-barand electrical lead assembly 105 is always outboard of lesion 18. As aresult, fiducial sensor 10 of J-bar assembly 115 can remain poweredthroughout the resection procedure, does not interfere with theresection procedure, and J-bar and electrical lead assembly 105 iscarried away with the resected tissue after resection has beencompleted.

As noted above, in one form of the invention, a bronchoscope 60 isadvanced through the airways of the patient until the distal tip ofbronchoscope 60 is disposed near the lesion (i.e., tissue mass) 18. Asalso noted above, the bronchoscope 60 may be advanced under directvisualization and its position may be tracked using one or more sensors180 carried by bronchoscope 60. Alternatively, the position ofbronchoscope 60 may be tracked using J-bar assembly 115, provided that atemporary electrical connection is provided for J-bar assembly 115(i.e., via an electrical connection extending through the interior ofneedle cannula 140, such as by electrifying a portion of pusher 145).Thus, it can be desirable to provide a temporary electrical connectionfor J-bar assembly 115 (i.e., via an electrical connection extendingthrough the interior of needle cannula 140, such as by electrifying aportion of pusher 145) so that J-bar assembly 115 can be powered whilethe J-bar assembly is in needle cannula 140.

It can also be desirable to provide a temporary electrical connectionfor J-bar assembly 115 (i.e., via an electrical connection extendingthrough the interior of needle cannula 140, such as by electrifying aportion of pusher 145) so that J-bar assembly 115 can be powered priorto connecting power supply clamping tool 190 to the portion of theelectrical lead 120 extending out of the lung.

In one preferred form of the invention, and looking now at FIG. 52A, atemporary electrical connection for J-bar assembly 115 can be providedas follows. Fiducial sensor 10 of J-bar assembly 115 comprises aproximal electrical connector 200 (as well as the electrical lead 120,which extends distally from fiducial sensor 10). Pusher 145 iscannulated and comprises a distal electrical connector 205. Electricalpower is provided to distal electrical connector 205 of pusher 145 by awire 210 which extends through pusher 145 (and which connects to a powersource, not shown). While J-bar assembly 115 is seated in needle cannula140, proximal electrical connector 200 of J-bar assembly 115 isconnected to distal electrical connector 205 of pusher 145, whereby topower fiducial sensor 10. After J-bar assembly 115 has been deployed inthe anatomy of a patient (and after prongs 20 have set in the tissue),pusher 145 is retracted, separating distal electrical connector 205 ofpusher 145 from proximal electrical connector 200 of J-bar assembly 115,thereby disconnecting J-bar assembly 115 from the power supplied by wire210 extending through pusher 145. However, it will be appreciated thatpower may still be delivered to J-bar assembly 115 via electrical lead120 and power supply clamping tool 190 (connected to electrical lead120).

Stapler Articulation Measurement

Surgical stapler heads can be articulated about a pivot point 220 toprovide the desired orientation while resecting the lesion. While theinstrument sensor 28 may be placed on the articulating head of thesurgical stapler 26 (e.g., such as is shown in FIGS. 8 and 9 ), this cancause interference from ferromagnetic material on the stapler head.Therefore, in practice, the instrument sensor 28 is typically positionedon the shaft of the surgical stapler 26, just proximal to thearticulation point, e.g., about 10 cm from the stapler tip, in order toavoid interference from ferromagnetic material on the stapler head. Inthis position, the instrument sensor 28 is proximal to the pivot point220 on the surgical stapler 26, so that the instrument sensor 28 sits onthe non-articulating portion of the stapler 26. See FIG. 53 . As aresult, the instrument sensor 28 placed on the non-articulating portionof the surgical stapler 26 does not capture the articulation motion ofthe surgical stapler 26.

Therefore, in another form of the invention, the surgical stapler 26 isconfigured to measure the articulation angle of the stapler head. Moreparticularly, an articulation sensor 225 is provided which preferablycomprises two parts. The first part 230 of the articulation sensor 225is placed on the stapler shaft. The second part 235 of the articulationsensor 225 is placed on the articulating stapler head. The connectionbetween the first and second parts 230, 235 of the articulation sensor225 is through a flexible encoder circuit that measures the angulationof the articulating end of the stapler head. The encoder circuit ispreferably a modified circular potentiometer to measure the angulationof the stapler head. See FIG. 54 . A Wheatstone bridge circuit measuresthe variable resistance produced on the encoder circuit so as toestimate the stapler articulation angle. In addition, the surgicalstapler 26 may also include an LED indicator (not shown) on the staplershaft to confirm the placement of the articulation sensor 225 on thesurgical stapler 26. Once the articulation sensor 225 is placed on thesurgical stapler 26, the circuit is completed to light up the LEDindicator.

If desired, the articulation sensor 225 may use schemes other thanelectrical resistance to measure stapler head articulation, e.g., anoptical encoder may be used to measure stapler head articulation, or amagnetic encoder may be used to measure stapler head articulation, etc.The articulation sensor 225 can also be internalized to the specificworking internal of the stapler device 26. Alternatively, a secondsensor (not shown) can be placed on an elastic extension from the sleevetowards the tip and past the articulation to allow direct measurement ofthe stapler articulation angle. This extension may be secured with tapeor other adhesive.

Marking the Boundary of a Resection Margin and Stapler Positioning

In one form of the invention, the lesion will be segmented from thediagnostic CT imaging so as to create a 3D model of the lesion 240 thatwill be inputted to the navigation system. In another form of theinvention, the lesion may be segmented based on a direct visualizationof the lesion by the surgeon, with or without input from radiologicfindings. Based on input from the surgeon or a machine learningalgorithm, the resection margin will be determined. A segmented modelfor the resection margin 245 is generated by expanding the lesion labelmap by the desired resection margin. See FIGS. 55 and 56 . Withknowledge of the position of the fiducial sensor (e.g., the T-bar orJ-bar assembly) and the lesion model 240, the position of the trackedsurgical stapler can be precisely estimated with respect to the lesionmodel 240 and the estimated resection margin model 245.

In addition to the foregoing, in one form of the invention, thenavigation software can guide the surgeon to precisely resect around thelesion, based on a distance to secure a sufficient margin defined by thesurgeon based on the mass size and presumed diagnosis. See FIGS. 57-59 .More particularly, in one form of the invention, and looking now at FIG.60 , the navigation software computes the tangent lines 250 at theperimeter of the modeled resection margin 245, and then guides thesurgeon to place the staples 255 just outside those tangent lines 250,so that the staples 255 follow a tangential path around the estimatedresection margin model 245.

Although the above described system and method for resecting a tissuemass was described for surgery involving the lung, it is also applicableto resection of lesions in any other organ or structure of the body, forexample, resection for breast conserving surgery, liver resection,sarcoma resection, partial nephrectomy or lung wedge resection surgery.In addition, the above described system and method for resecting atissue mass is not limited to VATS or minimally invasive surgery.

What is claimed is:
 1. A method for determining the position of aninstrument relative to a selected lumen in an anatomical structure, themethod comprising: positioning a tracked catheter in the selected lumenof the anatomical structure, wherein the tracked catheter is trackedrelative to a given frame of reference; and determining the position ofa tracked instrument relative to the tracked catheter, wherein thetracked instrument is tracked relative to the given frame of reference,whereby to determine the position of the tracked instrument relative tothe selected lumen of the anatomical structure.
 2. A method according toclaim 1 wherein a controller determines the position of the trackedinstrument relative to the tracked catheter by: determining the positionof the tracked catheter in the given frame of reference; determining theposition of the tracked instrument in the given frame of reference; anddetermining the difference between the position of the trackedinstrument in the given frame of reference and the position of thetracked catheter in the given frame of reference.
 3. A method accordingto claim 2 wherein the difference between the position of the trackedinstrument in the given frame of reference and the position of thetracked catheter in the given frame of reference is communicated to auser by at least one from the group consisting of: an audio cue; avisual cue; a quantitative cue; and a haptic cue.
 4. A method accordingto claim 3 wherein the visual cue comprises a virtual model of thetracked catheter and a virtual model of the tracked instrument, andfurther wherein the spatial relationship between the virtual model ofthe tracked catheter and the virtual model of the tracked instrument isthe same as the special relationship between the tracked catheter andthe tracked instrument in the given frame of reference.
 5. A methodaccording to claim 4 wherein the anatomical structure comprises a lung,and further wherein the selected lumen comprises an airway in the lung.6. A method according to claim 1 further comprising: using the trackedinstrument to resect a portion of the anatomical structure.
 7. A methodaccording to claim 6 wherein determining the position of the trackedinstrument relative to the selected lumen of the anatomical structure isused to spare the selected lumen of the anatomical structure duringresection.
 8. A method according to claim 6 wherein determining theposition of the tracked instrument relative to the selected lumen of theanatomical structure is used to excise the selected lumen of theanatomical structure during resection.
 9. A method according to claim 1wherein the anatomical structure comprises a plurality of lumensarranged in a tree-like structure, and further wherein the selectedlumen comprises one of the plurality of lumens.
 10. A method accordingto claim 9 wherein positioning the tracked catheter in the selectedlumen of the anatomical structure comprises: advancing a scope throughat least one of the plurality of lumens under the visual guidance of thescope; and advancing the tracked catheter through the scope to theselected lumen.
 11. A method according to claim 10 wherein the scope isadvanced to the selected lumen.
 12. A method according to claim 10wherein the scope stops short of the selected lumen, and the trackedcatheter is advanced out of the scope to the selected lumen.
 13. Amethod according to claim 9 wherein positioning the tracked catheter inthe selected lumen of the anatomical structure comprises: positioningthe tracked catheter in a scope; and advancing the scope through atleast one of the plurality of lumens under the visual guidance of thescope.
 14. A method according to claim 13 wherein the scope is advancedto the selected lumen.
 15. A method according to claim 13 wherein thescope stops short of the selected lumen, and the tracked catheter isadvanced out of the scope to the selected lumen.
 16. A method accordingto claim 1 wherein: the anatomical structure is deformable; the trackedcatheter is positioned in the selected lumen of the anatomical structurewhile the anatomical structure is in a first configuration; the trackedcatheter is maintained in position within the selected lumen of theanatomical structure while the anatomical structure transforms from thefirst configuration to a second configuration; and the position of thetracked instrument relative to the tracked catheter is determined whilethe anatomical structure is in its second configuration.
 17. A methodaccording to claim 16 wherein the tracked catheter is used to map aplurality of lumens of the anatomical structure while the anatomicalstructure is in a first configuration.
 18. A method according to claim16 wherein: a fiducial sensor is placed within the anatomical structurewhile the anatomical structure is in a first configuration; a trackedcatheter is placed in a selected lumen of the anatomical structure whilethe anatomical structure is in its first configuration; the relativedispositions of the fiducial sensor and the tracked catheter aredetermined while the anatomical structure is in its first configuration;the anatomical structure is transformed to a second configuration; therelative dispositions of the fiducial sensor and the tracked catheterare determined while the anatomical structure is in its secondconfiguration; and the change in the relative dispositions of thefiducial sensor and the tracked catheter is determined after theanatomical structure transforms from its first configuration to itssecond configuration and used to estimate the extent of anatomicalstructure deformation and the location of anatomy while the anatomicalstructure is in its second configuration.
 19. A system for determiningthe position of an instrument relative to a selected lumen in ananatomical structure, the system comprising: a catheter sized to bedisposable in the selected lumen of the anatomical structure; a cathetertracker for providing a catheter signal representative of the positionof the catheter tracker relative to a given frame of reference, thecatheter tracker being carried by the catheter; an instrument; aninstrument tracker for providing an instrument signal representative ofthe position of the instrument tracker relative to the given frame ofreference, the instrument tracker being carried by the instrument; and acontroller for determining the position of the tracked instrumentrelative to the tracked catheter, whereby, when the tracked catheter isdisposed in the selected lumen of the anatomical structure, thecontroller determines the position of the tracked instrument relative tothe selected lumen in the anatomical structure.
 20. A system accordingto claim 19 wherein the controller is configured to determine theposition of the tracked instrument relative to the tracked catheter by:determining the position of the catheter tracker in the given frame ofreference; determining the position of the instrument tracker in thegiven frame of reference; and determining the difference between theposition of the instrument tracker in the given frame of reference andthe position of the catheter tracker in the given frame of reference.21. A system according to claim 19 further comprising a user interface,and further wherein the user interface is configured to communicate to auser the difference between the position of the instrument tracker inthe given frame of reference and the position of the catheter tracker inthe given frame of reference, and further wherein the user interfacecommunicates with the user by using at least one from the groupconsisting of: an audio cue; a visual cue; a quantitative cue; and ahaptic cue.
 22. A system according to claim 21 wherein the visual cuecomprises a virtual model of the tracked catheter and a virtual model ofthe tracked instrument, and further wherein the spatial relationshipbetween the virtual model of the tracked catheter and the virtual modelof the tracked instrument is the same as the spatial relationship of thetracked catheter and the tracked instrument in the given frame ofreference.
 23. A system according to claim 19 further comprising a scopesized to receive the tracked catheter.
 24. A system according to claim19 wherein the anatomical structure is deformable, and further wherein,when the tracked catheter is disposed in the selected lumen of theanatomical structure while the anatomical structure is in a firstconfiguration, and the anatomical structure thereafter deforms to asecond configuration, the tracked catheter is configured to remain inthe selected lumen of the anatomical structure as the anatomicalstructure assumes the second configuration.